SES

RoslinCT, a contract manufacturer of advanced therapeutics, is working to develop pioneering standards to allow Digital Transformation in Cell Therapy Manufacturing. Industrializing Cell and Gene Therapies requires a paradigm shift for the pharmaceutical industry. Currently, the same approach is taken for made-to-stock, large-batch manufacture (200,000 doses per batch) as for made-to-order, personalized medicines (1 dose per batch).

Costs are too high: Healthcare systems cannot afford the medicines

This presentation will explore Bristol Myers Squibb's digital organizational transformation in partnership with JLL. Terri Melzer, Senior Director Global Facilities Services at Bristol Myers Squibb will join Pam Paddock as an expert speaker for this session. Together we will discuss how BMS is setting the foundation for future flexibility through cutting-edge technologies, AI-driven analytics, and cloud-based platforms.

The use of AI methods offers substantial potential, also in regulated areas, as evidenced by various case studies and implementations. However, with industry practices still evolving and regulatory guidance still early stage, organizations still face challenges to seize the potential of AI on scale, in lack of a harmonized and streamlined approach to managing the life cycle of an AI-enabled system and its AI sub-systems while maintaining patient safety, product quality and data integrity.

This presentation explores the practical considerations for designing pharmaceutical facilities in line with Pharma 4.0 principles. Early input in the design stages is crucial for the successful implementation of smart manufacturing solutions, as demonstrated by AstraZeneca's new API Clinical and Commercial Manufacturing Facility in Dublin. This state-of-the-art, paperless, digital smart factory integrates enterprise IT systems with operational technologies to enhance efficiency, quality, and innovation.

Pharmaceutical Research & Development has specific deliverables (target and lead ID, study design and execution, scaleup) and challenges in meeting these deliverables consistently (identifying and validating the right biological target, finding and optimizing a lead compound with sufficient properties, bridging the gap between animal and human models, developing reproducible, scalable production processes).

In today’s competitive landscape, an important factor in drug manufacturing is improving both machine efficiency and uptime. However, time for testing process optimizations on the machine is limited and costly in a running production process. A digital twin for creating and testing visual inspection recipes minimizes machine downtime and offers a significant productivity boost.

The role of quality assurance (QA) in IT validation projects is undergoing a fundamental change. While traditional document-based approaches often lead to a high administrative burden, the focus is increasingly shifting to a risk-based, system- and records-oriented approach. But what core competencies does QA need to add value to validation projects or to monitor them effectively? Which aspects can and should QA check in terms of content?

As data exchange within life sciences becomes increasingly decentralized, verifying and tracing source data within layered information systems presents a major challenge. Secure information networks and data sharing are critical. Blockchain-based technologies offer data security, transparency, and traceability. This session will explore various blockchain applications within the pharmaceutical industry, including decentralized identity, secure data storage, and formal verification.

Pharma’s digital transformation is no longer a question of "if" but "how fast" - yet securing buy-in, funding, and stakeholder alignment remains a challenge. Digital Maturity Assessments are proving to be a game-changer, offering a standardized, data-driven approach to measure readiness, justify investments, and drive enterprise-wide digital strategies for brownfield and greenfield facilities.

The use of digital health technology (DHT) in decentralized clinical trials (DCT) comes with challenges in the areas of auditing, provisioning, and validation, while meeting regulatory expectations outlined in FDA's Conducting Clinical Trials with Decentralized Elements, FDA's Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, and EMA guideline on computerized systems and electronic data in clinical trials.  In addition, ICH E6(R3) Annex 2 outlines GCP considerations for trials that incorporate decentralized elements, including